Product development

Polisano Pharmaceuticals provides pharmaceutical development and industrial-scale transfer services to ensure production under the required quality standards.

Pharmaceutical development services include preformulation and formulation studies, analytical development.

We are also able to ensure the manufacturing, packaging and labeling of the clinical investigation drugs.

Polisano Pharmaceuticals provides preformulation and manufacturing prescriptions evaluation for solid oral pharmaceutical forms as well as for controlled release medicines.

We have production capacities for:

  • tablets (film-coated, uncoated)
  • capsules

Contract manufacturing

With a high level of quality customer service, accurate documentation and timely delivery, we have succeeded in becoming a valuable partner for companies that have entrusted us with the production, control and release of pharmaceutical products.

Series control and batch release

  • Microbiological, biochemical and physico-chemical analytical methods are used both for testing during processing and for batch release. We provide testing of all raw materials, processing materials, packaging, finished products and stability samples.
  • The Quality Control Department is equipped according to GMP standards, the tests being performed and validated according to the European Pharmacopoeia.
  • We support the development, optimization and validation of new analytical methods and stability studies in line with ICH guidelines.

Development directions

The bioequivalence and phase I clinical studies center

We intend to support and complete the activity of the R&D department with phase I and bioequivalence studies for the launch of effective generic drugs on the local and global market – an essential element of the current business strategy. We provide to our external partners, bioequivalence studies, in accordance with the authorities' regulations, at competitive prices.

The bioequivalence clinical studies center and phase I is organized as follows: the clinical unit, the bioanalytical laboratory, pharmacokinetics and statistics.

Clinical Unit

Clinical Unit

We own an independent clinical unit, with a well-prepared medical staff and with a large expertise, making sure that the clinical studies are led in a very well controlled environment, complying with the regulations of protection and security of the subjects.

The Clinical Unit has a capacity of 26 beds (5 saloons, each with its own bathroom), information room, medical cabinets, emergency room, rooms with samples, meal room/recreation, all of them being equipped according to legislation requirements.

Bioanalytical laboratory

Bioanalytical laboratory

The Bioanalytical Laboratory is equipped with the latest medical equipment. In order to observe the flows of materials, biological samples, we have dedicated areas for primary processing, regular processing, analysis, sample storage.

The bioanalytical department and the experience of our laboratory staff, enable the development and validation of the bioanalytical methods, as well as the analysis of the biological samples that are resulted from the requested clinical trials.

What is a Bioequivalence study

Pharmacokinetics and statistics

Pharmacokinetics and statistics

Pharmacokinetic and statistical evaluation of the results is carried out by experts, using a globally approved software.

Our team provides extended pharmacokinetic and statistical support in clinical trials.